Product Approval Information
Proper Name: Antihemophilic Factor/von Willebrand Factor Complex (Human)
Tradename: Humate-P
Manufacturer: CSL Behring GmbH, License #1765
Package Insert (PDF - 337 KB) - October 19, 2007
Date: October 19, 2007
Labeling change: To include a change in the storage conditions (up to 25ºC) for the complete shelf life of 24 months
October 19, 2007 Approval Letter
FDA Approves Change in Storage Conditions for Humate-P (FDA News)
Date: April 27, 2007
Additional Indication: For adult and pediatric patients with von Willebrand disease for the prevention of excessive bleeding pre and post surgery
April 27, 2007 Approval Letter
Date: April 1, 1999
Indication: For use in adult patients for treatment and prevention of bleeding in hemophilia A (classic hemophilia) and in adult and pediatric patients for treatment of spontaneous and trauma-induced bleeding episodes in severe von Willebrand disease and in mild and moderate von Willebrand disease where use of desmopressin is known or suspected to be inadequate
April 1, 1999 Approval Letter
Summary Basis for Approval (PDF - 1.8 MB)
First Biologic Approved for Clotting Disorder (Talk Paper)